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NCT04622410 Clinical Trial

Registry for Hirschsprung Disease of the BELAPS

Hirschsprung Disease Clinical Trial

Official title:
Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04622410
Other study ID # S51836
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2012
Est. completion date December 31, 2030

Study information
Verified date May 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Colette Barle
Email colette.barle@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym / Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation

Recruitment information / eligibility
Status Recruiting
Enrollment 432
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: Hirschsprung Disease, surgery Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium. at least 10 years postoperatively
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